Women’s Health:
Related to maternal and child health, NCL worked with its Preterm Birth Prevention Alliance (PBPA) to prepare and present direct testimony as part of the FDA stakeholder hearing for Makena, which took place from October 17-19th. Makena is the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.
NCL prepared both internally and with Alliance members in strategizing for submitting both oral and written comments. Both NCL and various Alliance members submitted requests to provide oral comment, along with also submitting written comments to the public docket. Many diverse perspectives and stakeholders were represented throughout the two-and-a-half-day meeting through both oral and written comments, including those of patients, providers, and advocates. Executive Director Sally Greenberg and Health Policy Associate Milena Berhane both provided oral testimony during the hearing, in support of keeping Makena on the marketplace.
NCL is deeply disappointed by the FDA’s Obstetrics, Reproductive, and Urologic Drugs Advisory Committee vote to recommend that the FDA pursue withdrawal of approval of Makena. The final decision will be made by FDA Commissioner Robert Califf and is expected by the end of this year or early next. Despite this vote, NCL and the Preterm Birth Prevention Alliance will continue to advocate for mothers and babies who are at risk of preterm birth.
Access to Safe Medical Devices:
NCL is proud to advocate for consumer access to safe and effective FDA approved drugs and medical devices. Since December of 2021, NCL has been engaging with the FDA on the need for increased sound safety levels in establishing new Over the Counter (OTC) hearing aids. On August 16, 2022, FDA issued its final rule on OTC hearing aids for consumers with mild to moderate hearing loss. NCL has advocated for lowering the maximum output as well as establishing a gain limit for these devices. In its rule, FDA ultimately lowered the maximum outputs in the final rule but decided against establishing a gain limitation. NCL is pleased with the FDA’s lowering of the maximum output. However, NCL still advocates for the gain limit to be established, to ensure that consumers do not experience increased hearing loss through use of OTC hearing aids. NCL’s statement on the OTC hearing aid rule can be found here.
In addition, on August 3, 2022, NCL submitted comments to the FDA in support of the agency’s proposal to ban menthol products. In its comments, NCL discussed the importance of banning these products, and the public health harms that have been caused because of historical targeting of Black consumers by tobacco companies. NCL’s statement can be found here. Prior to submitting these comments, NCL’s Executive Director Sally Greenberg recorded a podcast with members of the African American Tobacco Control Leadership Council on this issue. The podcast can be found here.
Prescription Drug Pricing:
In support of advocacy efforts to raise awareness of the role Pharmacy Benefit Managers play in driving up prescription drug pricing, NCL has continued its work with the PBM Accountability Project coalition. This coalition brings together leaders and stakeholders across healthcare, labor, business, pharmacy, and consumer patient advocacy to help ensure that patients or our private and public sector health plans aren’t overpaying for the prescription medicines we need. NCL has also continued its engagement with the All Copays Count Coalition, which advocates for all copays and out-of-pocket costs to be fairly counted towards a patient’s deductible.
In late July, the Hill published an op-ed, written by Executive Director Sally Greenberg, on harmful PBM practices and the effects they have on consumer out-of-pocket drug costs. The op-ed can be found here.
More recently, on September 22, 2022, NCL hosted a virtual advocacy briefing to discuss the value of patient copay assistance programs and federal opportunities to protect vulnerable patient communities. This briefing was moderated by Executive Director Sally Greenberg, and included patient advocates, and policy experts.
NCL has prepared new educational materials about the role of PBMs to deploy at the beginning of the new year and the new Congress.
Vaccine Advocacy:
NCL has remained an advocate for increased access to and affordability of all CDC-recommended vaccines. Recently, NCL applauded the passage of the Inflation Reduction Act, which will provide all recommended adult vaccines to Medicare and Medicaid beneficiaries at no cost to patients. This is critical to increase access to vaccines and improving public health for consumers. The press release can be found here.
In addition, NCL continues its engagement with the Adult Vaccine Access Coalition (AVAC). The provisions in the Inflation Reduction Act related to vaccine cost-sharing include language from both the Protecting Seniors Through Immunization Act, and the Helping Adults Protect Immunity (HAPI) Act. These two bills have been spearheaded by AVAC and advocated for by NCL through both agency and congressional engagement.
Cannabis Consumer Watch:
NCL has rebranded its CBD consumer education campaign to the Cannabis Consumer Watch. The decision to pivot the advocacy campaign is in efforts to stay relevant as the congressional debate surrounding cannabis shifts. Current congressional outreach is focused on the response to the introduction of marijuana legalization legislation in the House. NCL is not taking a position on the legalization of marijuana. We are focused on public safety and ensuring the FDA maintains and exercises its authority to regulate cannabis products for consumers. The new website for the campaign can be found here.
